510(k) Report

Devices descending from K962699

848 later devices reach Radworks Medical Imaging Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation20200—
+9K192912AutoMIStarApollo Medical Imaging Technology Pty., Ltd.20190—
+9K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+9K192455Merge PACSMerge Healthcare Incorporated201904
+9K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+9K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+9K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+9K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+9K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+9K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+9K181892Ziostation2Ziosoft, Inc.20181—
+9K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+9K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+9K173771IOLMaster 700Carl Zeiss Meditec, AG201811
+9K180307Mazor XMazor Robotics, Ltd.201817—
+9K173390hipEOSOnefit Medical20188—
+9K180161Viz CTPViz. Ai, Inc.20182—
+9K172477iSchemaView RAPIDIschemaview, Inc.201817—
+9K180091UNiD Spine AnalyzerMedicrea International20186—
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+9K172522Mazor XMazor Robotics, Ltd.20170—
+9K161601DynamikaImage Analysis Limited20170—
+9K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+9K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+9K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+9K162468ClearCheckRadformation20164—
+9K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+9K152602Olea Sphere V3.0Olea Medical201617—
+9K151233MonacoImpac Medical Systems, Inc.201569
+9K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation20131—
+10K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+10K260086CadAI-B DxBeamWorks, Inc.20260—
+10K253835AffinityHermes Medical Solutions AB20260—
+10K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+10K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+10K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+10K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+10K253270Contour ProtégéAI+Mim Software, Inc.20260—
+10K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+10K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+10K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+10K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+10K250290SurgiTwinTwinsight20250—
+10K252362GBrain MRIGalileo Cds, Inc.20250—
+10K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+10K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+10K243301MapRTVision Rt, Ltd.20250—
+10K250099Mobius3D (4.1)Varian Medical Systems20250—
+10K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+10K242925MR Contour DLGE Healthcare20250—
+10K250042PeekMed webPeek Health, S.A.20254—
+10K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+10K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+10K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+10K243189TumorSight VizSimBioSys, Inc.20241—
+10K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+10K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+10K240582VEA Align; spineEOSEos Imaging20244—
+10K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+10K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+10K233634TeleScanBb Imaging20230—
+10K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+10K231353AccuCTP ProArteryFlow Technology Co., Ltd.20230—
+10K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+10K223834AccuCheckManteia Technologies Co., Ltd.20231—
+10K223091CT Perfusion V1.0Olea Medical20230—
+10K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+10K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+10K211059CereFlow™ V1.2Translational Mri, LLC20231—
+10K221627PerfusionGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+10K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+10K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+10K221432Customize3D-Side S.A.20220—
+10K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+10K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+10K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+10K212565CoverScan v1Perspectum, Ltd.20221—
+10K203744Arterys MICAArterys, Inc.20221—
+10K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+10K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+10K202793Cercare Medical NeurosuiteCercare Medical Aps20213—
+10K210919AcuityDReRadmedix, LLC20213—
+10K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation20210—
+10K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+10K203172MOSAIQ Oncology Information SystemElekta Solutions AB202081
+10K201948AcroDTI VisualizerAcroviz, Inc.20200—
+10K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+10K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+10K192692Brainomix 360 e-CTABrainomix Limited20203—
+10K200315Ziostation2Ziosoft, Inc.20200—
+10K192962icobrain-ctpIcometrix NV20200—
+10K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+10K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+10K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+10K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+10K182130iSchemaView RAPIDIschemaview, Inc.20189—